Provectus Biopharmaceuticals to Present Eight Rose Bengal Photodynamic Antimicrobial Therapy Studies at ARVO 2024

Provectus Biopharmaceuticals Inc. has shared significant insights regarding its rose bengal photodynamic antimicrobial therapy (RB PDAT) at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting. This prominent gathering, held in Seattle from May 5-9, 2024, attracts around 10,000 vision experts globally to discuss advances in ophthalmic research.

In April 2024, Provectus entered into an exclusive global license agreement with the University of Miami. This agreement focuses on intellectual property related to RB PDAT, which targets bacterial, fungal, and parasitic (acanthamoeba) eye infections. Provectus and the University plan to establish a new biotechnology company, tentatively named "Eyecare NewCo," possibly by the third quarter of 2024. This company will aim to commercialize a medical device designed by the University, paired with Provectus’s proprietary rose bengal active pharmaceutical ingredient (RB API).

RB PDAT has been a key research focus under the guidance of Dr. Jean-Marie Parel at the Bascom Palmer Eye Institute (BPEI) within the University of Miami Miller School of Medicine. Dr. Parel and his team have been developing this technology for over a decade to combat various forms of infectious keratitis.

Several presentations at ARVO 2024 highlighted the scope and efficacy of RB PDAT:

1. Evaluating the Safety of Rose Bengal Photodynamic Therapy by Huang et al., BPEI.
2. Rose Bengal Photodynamic Antimicrobial Therapy as an Adjuvant Treatment for Infectious Keratitis by Eskenazi-Betech et al., Instituto de Oftalmologia Fundacion Conde de Valenciana IAP, Mexico.
3. Assessment of Photosensitizer Concentration with a Singlet Oxygen Luminescence Dosimeter for Photodynamic Antimicrobial Therapy by Carrera et al., BPEI.
4. Clinical Outcome in Patients with Infectious Keratitis Treated with Rose Bengal Photodynamic Antimicrobial Therapy (RB-PDAT) at the Federal University of Sao Paulo (UNIFESP) by Tabuse et al., Universidade Federal de São Paulo, Brazil.
5. Enhanced Fungal Inhibition with High-Dose Rose Bengal Photodynamic Antimicrobial Therapy by Merikansky et al., BPEI.
6. Inhibition of Fungal Isolates via Singlet Oxygen Generation from Erythrosin B and Rose Bengal Photodynamic Antimicrobial Therapy by Ahmed et al., BPEI.
7. Arginine-Mediated Enhancement of Photodynamic Antimicrobial Therapy to Target the Oxygen-Independent Pathway by Gonzalez et al., BPEI.
8. Exploring the Combination of Rose Bengal Photodynamic Antimicrobial Therapy and Existing Antifungals by Krishna et al., BPEI.

RB PDAT is currently undergoing two international Phase 3 randomized controlled trials. These trials address acanthamoeba and fungal keratitis (NCT05110001), as well as bacterial keratitis (NCT06271772). Thus far, RB PDAT has been applied to patients with infectious keratitis in four countries:

- United States: Initial clinical reporting by BPEI (Naranjo et al., 2019).
- India: LV Prasad Eye Institute (Bagga et al., 2022) and Aravind Eye Care System with a data readout expected in Q4 2024 (NCT05110001).
- Brazil: Universidade Federal de São Paulo, presented at ARVO 2024.
- Mexico: Instituto de Oftalmología FAP, also presented at ARVO 2024.

The Bascom Palmer Eye Institute plays a crucial role in advancing ophthalmic research and patient care, consistently ranking as the top ophthalmology hospital in the United States. Meanwhile, Provectus Biopharmaceuticals continues to innovate in the biopharmaceutical field, focusing on halogenated xanthenes, with rose bengal sodium being a leading compound in their clinical and preclinical development programs.

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